Summary

for males ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide (with or without abiraterone acetate with prednisone [AAP]) before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo.

Official Title

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Keywords

Prostatic Neoplasms Prednisone Abiraterone Acetate Androgens Apalutamide Androgen Deprivation Therapy (ADT) Fixed-Dose Combination

Eligibility

You can join if…

Open to males ages 18 years and up

  • Histologically confirmed adenocarcinoma of the prostate
  • Candidate for radical prostatectomy as per the investigator
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Contraceptive (birth control) use by men (or female partners of men enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
  • Able to receive androgen deprivation therapy (ADT) for up to 1 year, per the investigator's assessment

You CAN'T join if...

  • Distant metastasis (clinical stage M1). Nodal disease below the iliac bifurcation(clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0
  • Prior treatment with anti-androgen
  • Prior treatment for prostate cancer
  • Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostat
  • History of any pelvic radiation

Locations

  • UC San Diego Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center not yet accepting patients
    Orange California 92868 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT03767244
Phase
Phase 3
Study Type
Interventional
Last Updated